meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
23
Latest Decision
2006-07-28

Clearances · page 77 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K061715 MRGFUS GENERAL PURPOSE AND BREAST COIL Insightec Txsonics, Inc. MOS Class II 2006-07-28
K061643 ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO Shimadzu Medical Systems IYN Class II 2006-07-27
K061964 SYNGO MULTIMODALITY WORKPLACE Siemens AG Medical Solutions LLZ Class II 2006-07-27
K060187 TOPSLANE DMLC Topslane International, LLC IXI Class II 2006-07-27
K061421 ERAD PACS Erad, Inc. LLZ Class II 2006-07-25
K061449 SYNGO EXPERT-1 Siemens Medical Solution JAK Class II 2006-07-25
K061893 INTEGRA RADIONICS XKNIFE RT 4 Integra Radionics, Inc. MUJ Class II 2006-07-25
K061582 VARISOURCE 200 HDR AFTERLOADER Varian Medical Systems, Inc. JAQ Class II 2006-07-25
K061429 DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA Esaote, S.p.A. LNH Class II 2006-07-25
K061637 ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO Shimadzu Medical Systems IYN Class II 2006-07-25
K061947 21.3 INCH MONOCHROME LCD MONITOR Nec Display Solutions , Ltd. LLZ Class II 2006-07-25
K061946 ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2006-07-21
K061713 MAGIS1;MAGIS2 Direx Systems Corp. IYE Class II 2006-07-21
K061447 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2) Totoku Electric Co., Ltd. LLZ Class II 2006-07-21
K060895 NOMOSSTAT, VERSION 1.0 Nomos Corp. IYE Class II 2006-07-21
K061418 QUANTIVA Tomographix IP , Ltd. LLZ Class II 2006-07-21
K061641 ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO Shimadzu Medical Systems IYO Class II 2006-07-14
K061682 GE VOLUSON E8 ULTRASOUND SYSTEM General Electric Co. IYO Class II 2006-07-12
K061817 LIGHTSPEED 7.1 CT SCANNER SYSTEM Ge Medical Systems, LLC JAK Class II 2006-07-12
K053584 IPLAN RT DOSE Brainlab AG MUJ Class II 2006-07-12
K061310 ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEM Ziehm Imaging, Inc. JAK Class II 2006-07-07
K061534 ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM Ziehm Imaging, Inc. OWB Class II 2006-07-07
K061540 LEKSELL GAMMAPLAN Elekta Instrument AB IWB Class II 2006-07-05
K061525 GE VIVID - I General Electric Co. IYN Class II 2006-07-03
K061545 SCENIUM 1.1 Siemens Molecular Imaging, Ltd. KPS Class II 2006-06-30
K061538 ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200 Alara, Inc. MQB Class II 2006-06-30
K061488 CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM Shantou Institute of Ultrasonic Instruments (Siui IYN Class II 2006-06-30
K061672 SYNAPSE MIP/MPR IMAGE VISUALIZATION SOFTWARE OBLIQUUS Fujifilm Medical Systems U.S.A, Inc. LLZ Class II 2006-06-29
K061671 SYNGO TRUED, MODEL VC10A Siemens Medical Solutions LLZ Class II 2006-06-29
K061440 P.D .Decimal, Inc. MUJ Class II 2006-06-27
K061624 VITREA, VERSION 3.9 Vital Images, Inc. LLZ Class II 2006-06-27
K061625 AUTOBONE2 GE Healthcare JAK Class II 2006-06-26
K061587 FULLCARD ANALYSIS GE Healthcare KPS Class II 2006-06-23
K061302 DIGITAL PRINTER P6000D SERIES, MODEL P6000DU Mitsubishi Electric Corporation Kyoto Works LMC Class II 2006-06-23
K060483 VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM Volcano Corporation IYO Class II 2006-06-23
K061605 NEMIO XG, SAA-580A Toshiba America Medical Systems, In.C IYN Class II 2006-06-22
K061203 ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM Ziehm Imaging, Inc. OWB Class II 2006-06-19
K061281 INSIGHT HEAD COIL Insight Neuroimaging Systems, LLC MOS Class II 2006-06-19
K061437 SIGMA 5000 SERIES, IMAGIC Kontron Medical Systems Sas IYN Class II 2006-06-14
K061255 BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0 Kyron Clinical Imaging, Inc. LNH Class II 2006-06-13
K061051 DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER Sicel Technologies, Inc. LHN Class II 2006-06-13
K061160 M-VU CAD STATION Vucomp, Inc. LLZ Class II 2006-06-09
K061472 GALILEOS IMPLANT, V 1.0 Sicat GmbH & Co. KG LLZ Class II 2006-06-09
K061173 CPIVISION DIGITAL IMAGING SYSTEM Communications & Power Industries Canada, Inc. OWB Class II 2006-06-09
K061163 INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT Ge Medical Systems, LLC OWB Class II 2006-06-07
K061061 20.1-INCH (51CM) COLOR LCD MONITOR CDL2009A (CCL204) Tokotu Electric Co., Ltd. LLZ Class II 2006-06-07
K061028 PRECISION THUNIS 800+ Ge Medical Systems, LLC JAA Class II 2006-06-07
K061097 COHERENCE DOSIMETRIST, MODEL 2.2 Siemens Medical Solutions USA, Inc. MUJ Class II 2006-06-07
K052661 QUIX DIGITAL RADIOGRAPHIC UPGRADE Edge Medical Devices , Ltd. MQB Class II 2006-06-07
K061083 CTS-7700 Shantou Institute of Ultrasonic Instuments IYO Class II 2006-06-06
K060299 ART BRACHYTHERAPY APPLICATOR Advanced Radiation Therapy, LLC JAQ Class II 2006-06-06
K061035 TIGERVIEW PROFESSIONAL Televere Systems LLZ Class II 2006-06-05
K060937 BRILLIANCE VOLUME Philips Medical Systems (Cleveland), Inc. JAK Class II 2006-06-05
K061006 IKOENGELO Ikoetech, LLC KPQ Class II 2006-06-05
K061129 GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000 General Electric Co. IYN Class II 2006-06-01
K061189 DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYO Class II 2006-06-01
K061372 CENTRICITY AW SUITE OPTION Ge Healthcare Information Technologies LLZ Class II 2006-05-30
K061396 QLAB QUANTIFICATION SOFTWARE Philips Ultrasound, Inc. LLZ Class II 2006-05-30
K061370 CARDIQ FUSION GE Healthcare JAK Class II 2006-05-30
K061303 MEDICAL DISPLAY, MODELS MDM 1900-1NG AND MDM 1900-1NR Chi Lin Technology Co., Ltd. LLZ Class II 2006-05-25
K061305 MEDICAL DISPLAY, MDC1900-1LG (1LR) Chi Lin Technology Co., Ltd. LLZ Class II 2006-05-25
K061326 VOXAR 3D ENTERPRISE WITH CARDIAMETRIX Barcoview Mis Edinburgh LLZ Class II 2006-05-25
K061170 3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000 Resonance Innovations, LLC MOS Class II 2006-05-25
K061132 MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035 Neusoft Medical Systems Co., Ltd. LNH Class II 2006-05-24
K060827 MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100 Esaote, S.p.A. IYN Class II 2006-05-19
K060950 3MATIC Materialise NV LLZ Class II 2006-05-18
K061213 SONOACE PICO DIAGNOSTIC ULTRASOUND SYSTEM Medison Co., Ltd. IYN Class II 2006-05-16
K060816 MIM 4.0 (NEURO Mimvista Corp. LLZ Class II 2006-05-16
K060870 AVANZA Mds Nordion JAI Class II 2006-05-15
K061140 TRILOGY RADIOTHERAPY DELIVERY SYSTEM Varian Medical Systems IYE Class II 2006-05-15
K061214 AQUARIUSAPS SERVER Terarecon,Inc. LLZ Class II 2006-05-15
K061187 TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING Toshiba America Medical Systems, In.C JAK Class II 2006-05-12
K060903 IG4 IMAGE GUIDED SYSTEM Veran Medical Technologies, Inc. JAK Class II 2006-05-11
K061152 MUCHECK V7.0 Oncology Data Systems, Inc. LHN Class II 2006-05-10
K061126 ACCUREX Cybermed, Inc. LLZ Class II 2006-05-09
K061054 AXIOM ARISTOS FX PLUS Siemens Medical Solutions USA, Inc. MQB Class II 2006-05-09
K060112 NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEM Nodecrest, LLC IYN Class II 2006-05-05
K060758 OR HEAD COIL 1.5 T Siemens Medical Solutions USA, Inc. MOS Class II 2006-05-05
K060671 KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS Wfr/Aquaplast Corp. JAI Class II 2006-05-04
K060956 G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004 Esaote, S.p.A. LNH Class II 2006-05-04
K060949 DP-6600 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYO Class II 2006-05-04
K060993 GE LOGIQ P5 AND A5 General Electric Co. IYN Class II 2006-05-03
K060867 SPY INTRAOPERATIVE IMAGING SYSTEM Novadaq Technologies, Inc. IZI Class II 2006-05-03
K060633 COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.0 Siemens Medical Solutions USA, Inc. IYE Class II 2006-05-01
K061029 JETSTREAM WORKSPACE Adac Laboratories LLZ Class II 2006-05-01
K060961 15-INCH (38CM) COLOR LCD MONITOR CDL1566A Totoku Electric Co., Ltd. LLZ Class II 2006-05-01
K061018 PLANAR DOME EX LINE MODEL DOME E2C Planar Systems, Inc. LLZ Class II 2006-04-28
K060992 SYNGO US WORKPLACE Siemens Medical Solutions LLZ Class II 2006-04-28
K060845 MONOCHROME LCD MONITOR, RADIFORCE MODEL GS310 Eizo Nanao Corporation LLZ Class II 2006-04-25
K060111 IVA (MXA II SOFTWARE OPTION) Hologic, Inc. KGI Class II 2006-04-24
K060679 SURTRAK IMPLANTATION KIT North American Scientific, Inc. KXK Class II 2006-04-21
K060912 MODIFICATION TO: HI-ART SYSTEM Tomotherapy Incorporated IYE Class II 2006-04-19
K060834 PROBEAT WITH MGCS Hitachi , Ltd. LHN Class II 2006-04-19
K052947 SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE Source Production & Equipment Co., Inc. JAQ Class II 2006-04-19
K053610 ABARIS Traxtal Technologies, Inc. JAK Class II 2006-04-19
K060636 PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE C.R. Bard, Inc. KXK Class II 2006-04-19
K060879 MODEL EC9-4 TRANSDUCER Siemens Medical Solutions USA, Inc. ITX Class II 2006-04-19
K060947 SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020 Boston Scientific Corp ITX Class II 2006-04-19
K060941 CAAS MRV VERSION 3.0 Pie Medical Imaging BV LLZ Class II 2006-04-19
K053306 IVIEW Ondemandsoft IYO Class II 2006-04-19

14,721 clearances in the Radiology panel. Data: openFDA.